Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-30 @ 7:55 AM
Study NCT ID:
NCT06471257
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Multicentre, Event-driven, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Symptomatic Chinese Adults With Asthma (BAIYUN)
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAIYUN
Brief Summary:
An event-driven, Phase III study to evaluate the efficacy and safety of BDA MDI compared with AS MDI in reducing the risk of a severe asthma exacerbation in symptomatic Chinese adults with asthma.
Detailed Description:
This is a randomized, double-blind, multicenter, event-driven, parallel group, Phase III study to assess the efficacy and safety of budesonide and albuterol metered dose inhaler (MDI) versus albuterol sulfate (AS) MDI in symptomatic Chinese adults with asthma. Both treatments will be administered as needed in response to asthma symptoms or prior to exercise. Approximately 790 participants who meet the eligibility criteria will be randomized.
The study will consist of 3 periods:
1. Screening period: 14 to 28 days
2. Treatment period: minimum of 24 weeks and maximum of 52 weeks
3. Safety follow-up period: occur 2 weeks (± 4 days) after Visit 8, EOS or PDV, whichever occurs first
790 participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to receive one of the following 2 treatments to be used as reliever therapy on top of usual maintenance treatment:
* BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 µg) as needed
* AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg) as needed
The study will consist of 3 periods:
1. Screening period: 14 to 28 days
2. Treatment period: minimum of 24 weeks and maximum of 52 weeks
3. Safety follow-up period: occur 2 weeks (± 4 days) after Visit 8, EOS or PDV, whichever occurs first
790 participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to receive one of the following 2 treatments to be used as reliever therapy on top of usual maintenance treatment:
* BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 µg) as needed
* AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg) as needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: